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L'essai clinique NCT07248774 pour Épanchement pleural est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion

En recrutement
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L'étude clinique NCT07248774 est un essai interventionnel pour Épanchement pleural. Son statut actuel est : en recrutement. L'étude a débuté le 28 octobre 2025 et vise à recruter 40 participants. Dirigé par l'Université internationale Riphah, l'essai devrait être terminé d'ici le 15 janvier 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 novembre 2025.
Résumé succinct
Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.
Description détaillée
Pleural effusion is the pathological accumulation of excess fluid in the pleural cavity, compromising lung function by limiting expansion and reducing compliance. This condition leads to symptoms such as dyspnea and impaired gas exchange, which can significantly affect pediatric patients. Treatment often includes physical therapy techniques to facilitate lung expansion and improve respiratory function. The present study comprises Bubble Positive Expiratory Pressure, which involves exhalation through water to create resistance and improve expiratory volume, and Segmental Breathing, which enhances inspiratory volume for lung expansion. In contrast, Incentive Spirometry provides visual feedback to guide deep inhalation; it includes both upside and upside-down usage of the spirometer for the maintenance of pulmonary function and preventing alveolar collapse.

Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.

Titre officiel

Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With Pleural Effusion

Conditions
Épanchement pleural
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • REC/RCR&AHS/TAYYBABARI
Numéro NCT
Date de début (réel)
2025-10-28
Dernière mise à jour publiée
2025-11-25
Date de fin (estimée)
2026-01-15
Inscription (estimée)
40
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Pleural effusion, PEP, Segmental Breathing, Dyspnea
Objectif principal
Autre
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifGroup A: Intervention Group (Bubble PEP + Segmental Breathing)
The experimental group will receive Bubble PEP therapy and Segmental Breathing along with conventional chest physiotherapy and mobility training. Bubble PEP will be performed using a bottle device where children exhale through a water-submerged tube, creating resistance to improve lung expansion and secretion clearance (10 repetitions, progressing from 1 to 3 sets over 14 days). Segmental Breathing will focus on localized lung expansion with therapist-guided tactile feedback, performed at six breaths per minute, progressing from 1 to 3 sets. Chest percussion will be applied for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters. All sessions will be conducted once daily for two weeks.
Bubble PEP
Bubble PEP will be performed using a bottle device with 10 repetitions, progressing from one to three sets over 14 days. Segmental Breathing will target localized lung expansion with six breaths per minute, progressing similarly. Chest percussion will be applied on the contralateral side for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters across the intervention period. All sessions will be conducted once daily for two weeks, with pre- and post-intervention assessments of lung expansion and dyspnea.
Comparateur actifGroup B: Control Group (Incentive Spirometry)
Participants in the control group will receive Incentive Spirometry along with conventional chest physiotherapy and mobility training. Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session. Chest percussion will be administered on the contralateral side to facilitate secretion mobilization, performed for two minutes on Days 1-3, three minutes on Days 4-7, and five minutes on Days 8-14, with 15 seconds of rest after each minute. Mobility training will include walking exercises, starting from one meter on Day 1, increasing to three meters by Day 3, and progressing to five meters from Day 4 onward, performed in two sets during Days 8-14. All sessions will be conducted once daily for two weeks.
Incentive Spirometery
Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Lung Expansion
To assess lung expansion before and after the intervention, anteroposterior chest X-rays will be used to evaluate improvements in lung volume and potential reductions in pleural effusion. This method allows for the measurement of lung field dimensions, changes in the opacity of lung areas affected by pleural effusion, and overall changes in thoracic structure that might indicate therapeutic effectiveness.
Baseline, 2 weeks
Pediatric Dyspnea Scale
The Pediatric Dyspnea Scale (PDS) assesses subjective dyspnea in pediatric patients by using a visual and numerical scale, where patients indicate their perception of breathlessness. The PDS is scored from 1 through 7 where 1 indicates "No trouble at all" breathing and 7 indicates "Very much trouble" and a score of 1 through 7 was assigned accordingly.
Baseline, 2 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Chest Expansion
Chest expansion will be measured with the help of tape method at different stages of the chest which measures symmetry and extent of expansion. The levels of measurements are at sternal notch, at xiphoid process and at T8vertebral level.
Baseline, 2 weeks
Oxygen Saturation
Oxygen saturation (SpO2) will be measured using a pulse oximeter to evaluate improvements in oxygenation resulting from enhanced lung function.
Baseline, 2 weeks
Respiratory Rate
The respiratory rate can be manually counted or evaluated using respiratory monitoring equipment, offering an objective measure of respiratory efficiency.
Baseline, 2 weeks
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
5 Years
Sexes éligibles
Tous
  • Age 5 to 16.
  • Suffering from Pleural effusion or hydrothorax.
  • Thoracic drainage system in situ for 24 hours.
  • Either gender will be included.
  • Patients without any other co-existing illness.

  • Any other pulmonary pathology that does not fit the diagnostic criteria of Pleural Effusion.
  • Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax, chest trauma or rib fracture.
  • Participants with other comorbidities leading to pleural effusion.
  • Patients who have chest musculoskeletal deformities.
Riphah International University logoUniversité internationale Riphah
Contact central de l'essai
Contact: IMRAN AMJAD, PhD, 9233224390125, [email protected]
Contact: Muhammad Asif Javed, MS-PT, 923224209422, [email protected]
1 Centres de l'essai dans 1 pays

Punjab Province

The Children Hospital and University of Child Health Sciences, Lahore, Punjab Province, 54000, Pakistan
IMRAN AMJAD, PhD, Contact, 9233224390125, [email protected]
Muhammad Asif Javed, MS-PT, Contact, 923224209422, [email protected]
En recrutement